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NCT04471155 Clinical Trial

Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04471155
Other study ID # MD/152/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date April 22, 2020

Study information
Verified date July 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date April 22, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender Male
Age group 55 Years and older
Eligibility Inclusion Criteria:

- American Urological Association Symptom Score of eight or higher,

- Maximum urinary flow rate of 10ml/s or less,

- Post void residual urine volume of 50 ml or more,

- And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).

Exclusion Criteria:

- A previous prostate or urethral surgery

- And non-BPH related voiding disorders

- Prostate cancer patients

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Holep
laser enucleation of the gland versus open enucleation

Locations
Country Name City State
Egypt Mohamed Alnoomani Cairo ???????

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficacy by measuring maximum urinary flow rate in millilitre per second change of maximum urinary flow rate in mililiter per second pre and post opeartive 1 year
Primary efficacy in american urological association symptom score change of american urological association symptom score pre and post operative by scale from 1 to 35 1 year
Primary efficacy of evacuation by measuring post-voiding residual urine volume in millilitre change of post-voiding residual urine volume in millilitre 1 year
Secondary safety by doing blood picture to asses hemoglobin drop rate of hemoglobin drop post-operatively by gram per decilitre immediate post-operative
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